Drugs

Covid Real-World Data Agreement Signed

FDA says it has agreed with Aetion to collaborate on advanced analytical techniques to answer urgent Covid-19 research questions. Aetion says it has developed “scientifically validated software for performing rapid analyses to generate real-world evidence at scale.” An online statement from principal deputy commissioner Amy Abernathy says FDA and Aetion want to answer questions about using diagnostics and medications in the pandemic, and risk factors for Covid-19-related complications in different patient populations. “We believe that this work has the potential to contribute to the scientific evaluation of potential diagnostic and interventions for Covid-19,” she writes.

The statement says the agency has worked quickly to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources. “Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity, and understand available medical product supplies to help mitigate potential shortages,” Abernathy writes. “These data can also inform ongoing work to evaluate potential therapies, vaccines, or diagnostics for Covid-19.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome